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EFHSS Questions and Answers - Answer to Question Q00136

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EFHSS - Questions & Answers - Low Temperature Sterilization - Q00136
Restrictions on ethylene oxide sterilisation 		Follow Up
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From: (India)   Date: 25 March 2002, 15:19 [GMT]
Subject: Restrictions on ethylene oxide sterilisation

Dear Sirs,

Since ethylene Oxide is a carcinogenic substance, its use is being widely banned. However, still it is regularly used in India to sterilise Disposable Petri plates since the regulatory authority (FDA, Indian Pharmacoepia) does not ban its use.

Does the US, British or European Pharmacoepia's or authorities have any restrictions with regards to ethylene oxide sterilisation on disposable petri plates made of polystyrene. If yes Why? Can I have some references.

Thanks
SM Walavalkar
From: (Netherlands)   Date: 27 March 2002, 16:09 [GMT]
Subject: Re: Restrictions on ethylene oxide sterilisation

Sir,

The European Agency for the Evaluation of Medicinal Products states that EO may only be used "where safer alternatives can not be used". This means that the user has to prove that other methods of sterilization can not be employed. However, it does not forbid the use of EO.

Arjan van Drongelen
National Institute for Public Health and the Environment (RIVM)
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